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The FDA’s approval of Aduhelm “raised concerns due to alleged scientific disputes within the FDA, the advisory committee’s vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA’s use of the accelerated approval pathway,” HHS said. Read More
Last month, the FDA granted the Pfizer-BioNTech COVID-19 vaccine a priority review for full approval, and the agency has also reallocated staff resources and said it is taking an “all hands on deck” approach. Read More
The FDA has granted Eiger BioPharmaceuticals Breakthrough Therapy designation for avexitide for the treatment of congenital hyperinsulism, an ultra-rare, life-threatening pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to half of children affected. Read More
There is currently no approved vaccine for RSV, a common respiratory virus that generally causes cold-like symptoms but can be fatal for elderly adults and young children. Read More
Saphnelo’s approval is only the third FDA approval of a new therapy across all types of lupus in 60 years, according to the Lupus Foundation of America. Read More
Opdivo previously received FDA approval in May as an adjuvant for patients with completely resected GEJ cancer with residual pathologic disease following chemoradiotherapy. Read More
The FDA revised its emergency authorization of Regeneron’s antibody cocktail, REGEN-COV (casirivimab/imdevimab), to include its use for prevention of COVID-19 infection in individuals 12 years and older who have been exposed to the coronavirus and are at high risk of progressing to severe disease. Read More